(168 days)
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No
The device description focuses on the physical components and materials of a blood tubing set for hemodialysis, with no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
No
The device is a blood tubing set used during hemodialysis, which is part of an artificial kidney system for treating renal failure. It facilitates access to a patient's blood but does not directly provide a therapeutic effect itself; rather, it is a component of a larger therapeutic system.
No
The device description indicates it is a set of tubing and accessories for use during hemodialysis, which is a treatment process, not a diagnostic one.
No
The device description clearly outlines multiple physical components made of various materials (polyethylene, PVC, etc.), indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use during hemodialysis to provide access to a patient's blood." This describes a device used in vivo (within the body) to facilitate a medical procedure, not a device used in vitro (outside the body) to examine specimens from the body.
- Device Description: The description details components like blood tubing sets, a solution infusion set, and transducer protectors. These are all components used to manage blood flow and pressure during hemodialysis, which is a treatment procedure.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening
The device is a medical device used for a therapeutic procedure (hemodialysis), not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set is intended for use during hernodialysis to provide access to a patient's blood. When used in hemodialysis, they are part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.
Product codes (comma separated list FDA assigned to the subject device)
78 KOC
Device Description
The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set that we intend to market includes the following three components: a Nipro® Arterial and Venous Blood Tubing Set for Hemodialysis; a Nipro® Disposable Solution Set ; and, a transducer/ protector. These devices are packaged together for convenient use during hemodialysis procedures.
The Arterial and Venous Blood Tubing Sets that we intend to include within the kits include various models of blood tubing sets are available for application with different dialysis machines. A series of 27 arterial line models (A001 - A021, A026, A029 -A032, and A035) and a series of 14 venous line models (V600 - V607, V609 - V613, and V616) have been described. The Disposable Solution Infusion Set that we intend to include in the kit will be one of the 4 types of designs: NNC-3L, NNC-3CL. NNC-3C. and NNC-3CS. A transducer/protector is also included in the kit.
The materials used for the components of the blood tubing sets include polyethylene (PE), polyvinylchloride (PVC), acrylonitrate butadiene styrene (ABS), polyoxymethylene (POM), polypropylene (PP), polyethylene high density (PEHD), and polycarbonate (PC). The materials used for the disposable solution infusion set include polyethylene (PE), polyvinylchloride (PVC), polypropylene (PP), and acrylonitrate butadiene styrene (ABS). The transducer/protector component of this kit is fabricated from either rigid PVC and a 0.2 micron Gore membrane (PTFE and polypropylene) or rigid PVC and PTFE and polyester.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following biocompatibility tests were performed on the components of the subject device kit: cytotoxicity, mutagenicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, implantation tests, pyrogenicity, and sensitization. Results indicate that the blood tubing sets conform to the appropriate specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 876.5820 Hemodialysis system and accessories.
(a)
Identification. A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient.
(2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860).
(3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860).
(4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
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K972206 PAGE 1 OF 3
Image /page/0/Picture/2 description: The image shows the logo for Nipro. The logo consists of a stylized infinity symbol to the left of the word "NIPRO" in bold, sans-serif font. The infinity symbol is made up of two interlocking loops, and the word "NIPRO" is in all caps.
CORPORATION 0877 N.W. 33rd Street Miami. Florida 33172 Tel .: (305) 599-7174 Fax: (305) 599-8454
SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set
$807.92 (a)(1)
Submitter:
Nipro Medical Corporation
Contact Person:
Luis Candelario General Manager
September 24, 1997
Date of Summary Preparation:
$807.92 (a)(2)
| Trade Name: | Nipro® Blood Tubing Set for Hemodialysis
withTransducer Protectors and Priming Set |
|----------------------|---------------------------------------------------------------------------------------|
| Common Name: | Blood tubing set with priming set and transducer/protectors |
| Classification Name: | Blood access device and accessories (21 CFR
876.5540) |
$807.92 (a)(3)
Legally Marketed Substantially Equivalent Devices:
Medisystems Corporation ReadySet™ Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors
8807.92 (a)(1)
Description of Device:
The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set that we intend to market includes the following three components: a Nipro® Arterial and Venous Blood Tubing Set for Hemodialysis; a Nipro® Disposable Solution Set ; and, a transducer/ protector. These devices are packaged together for convenient use during hemodialysis procedures.
1
page 2 - SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® Blood Tubing Set for Hemodialysis with Transducer/Protectors and Priming Set
The Arterial and Venous Blood Tubing Sets that we intend to include within the kits include various models of blood tubing sets are available for application with different dialysis machines. A series of 27 arterial line models (A001 - A021, A026, A029 -A032, and A035) and a series of 14 venous line models (V600 - V607, V609 - V613, and V616) have been described. The Disposable Solution Infusion Set that we intend to include in the kit will be one of the 4 types of designs: NNC-3L, NNC-3CL. NNC-3C. and NNC-3CS. A transducer/protector is also included in the kit.
The materials used for the components of the blood tubing sets include polyethylene (PE), polyvinylchloride (PVC), acrylonitrate butadiene styrene (ABS), polyoxymethylene (POM), polypropylene (PP), polyethylene high density (PEHD), and polycarbonate (PC). The materials used for the disposable solution infusion set include polyethylene (PE), polyvinylchloride (PVC), polypropylene (PP), and acrylonitrate butadiene styrene (ABS). The transducer/protector component of this kit is fabricated from either rigid PVC and a 0.2 micron Gore membrane (PTFE and polypropylene) or rigid PVC and PTFE and polyester.
8807.92 (a)(5)
The Blood Tubing Set for Hemodialysis with Transducer Protectors Intended Use: and Priming Set is intended for use during hemodialysis to provide access to a patient's blood. When used in hemodialysis, they are part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.
8807.92 (a)(6)
Comparison of Technical Characteristics:
The configuration of the subject device kit is similar to legally marketed devices from Medisystems Corporation. Labeling for the competitor's devices is similar to the subject device. According to the device names on the labeling, the intended use for the competitors' products is similar to that of the subject device. They are used for hemodialysis. All of the devices are labeled as sterile and for single use only. The devices are restricted to sale by or on the order of a physician. The blood tubing sets and disposable solution infusion sets are already cleared for market individually and demonstrated to be biocompatible according to necessary testing and prior clinical use. The transducer/protector is fabricated from identical materials to those contained in certain blood tubing set components. Transducer/protectors have also undergone biocompatibility testing and are similar to marketed components.
2
page 3 - SUMMARY OF SAFETY AND EFFECTIVENESS FOR NIPRO® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set
- The following biocompatibility tests were performed on the components of $807.92 (b)(1) the subject device kit: cytotoxicity, mutagenicity, hemolysis, acute systemic toxicity, intracutaneous reactivity, implantation tests, pyrogenicity, and sensitization. Results indicate that the blood tubing sets conform to the appropriate specifications.
- The Nipro Disposable Blood Tubing Set for Hemodialysis and Disposable $807.92 (b)(3) Solution Infusion Set have already been determined to be substantially equivalent to legally marketed devices. The transducer/protector is composed of materials identical to those contained in blood tubing set components and similar to marketed components.
3
Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 1997
Mr. Luis Candelario General Manager Nipro Medical Corporation 10877 N.W. 33rd Street Miami, Florida 33172
Re: K972206 Nipro® Blood Tubing Set with Transducer Protectors and Priming Set for Hemodialysis Dated: August 27, 1997 Received: September 4, 1997 Regulatory Class: II
21 CFR §876.5820/Product code: 78 KOC
Dear Mr. Candelario:
We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions; or other Federal Laws or Regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general
4
Page 2 - Mr. Luis Candelario
information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Robert R. Setting/
Lillian W. Ph.D.
$\xi$
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K972206
Device Name: Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set
Indications for Use: The Nipro® Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming Set is intended for use during hernodialysis to provide access to a patient's blood. When used in hemodialysis, they are part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use J (Per 21 CFR 801.109)
OR
Over-The-Counter Use
Robert L. Satterly/
(Division Sign-Off) -2-Division of Reproductive, Abdominal, ENT, and Radiological Devices (972206 510(k) Number_